ESSENTIAL DENTAL SYSTEMS, INC.

Address:89 LEUNING ST.,S Hackensack,NJ,07606,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

POST, ROOT CANAL (ELR) (5) CEMENT, DENTAL (EMA) (3) AGENT, TOOTH BONDING, RESIN (KLE) (1) DRILL, DENTAL, INTRAORAL (DZA) (1)

Premarket Exempt

No Yes

Clear

EZ-Fill Bi-Directional Spiral - 00766054000303 Catalog Number : 1605-01

Device Description : EZ-Fill Bi-Directional Spiral 21mm & 25mm Nickel Titanium

Device Class : 1

Duns Number: 101147171

Premarket Exempt : Yes

Product Code : DZA

Prescription Use : Yes

Device Count : 1

ENVY Self Adhesive Resin Cement-Translucent Shade - 00766054000310 Catalog Number : 960-00

Device Description : Resin Cement Syringeable Dual Cure Translucent Shade

Device Class : 2

Duns Number: 101147171

Premarket Exempt : No

Product Code : EMA

Prescription Use : Yes

Device Count : 1

ENVY Self Adhesive Resin Cement-White Opaque Shade - 00766054000327 Catalog Number : 970-00

Device Description : Resin Cement Syringeable Dual Cure White Opaque Shade

Device Class : 2

Duns Number: 101147171

Premarket Exempt : No

Product Code : EMA

Prescription Use : Yes

Device Count : 1

ENVY Self Adhesive Resin Cement-A2 Shade - 00766054000334 Catalog Number : 980-00

Device Description : Resin Cement Syringeable Dual Cure A2 Shade

Device Class : 2

Duns Number: 101147171

Premarket Exempt : No

Product Code : EMA

Prescription Use : Yes

Device Count : 1

EDS Self Etch Bonding Agent - 00766054000341 Catalog Number : 900-00

Device Description : Self Etch Bonding Agent

Device Class : 2

Duns Number: 101147171

Premarket Exempt : No

Product Code : KLE

Prescription Use : Yes

Device Count : 1

AccessPost - 00766054000358 Catalog Number : 500-00

Device Description : AccessPost Intro

Device Class : 1

Duns Number: 101147171

Premarket Exempt : Yes

Product Code : ELR

Prescription Use : Yes

Device Count : 1

AccessPost - 00766054000365 Catalog Number : 500-12

Device Description : AccessPost Intro

Device Class : 1

Duns Number: 101147171

Premarket Exempt : Yes

Product Code : ELR

Prescription Use : Yes

Device Count : 1

AccessPost - 00766054000372 Catalog Number : 530-0

Device Description : AccessPost Refill 10 Pack Size 0

Device Class : 1

Duns Number: 101147171

Premarket Exempt : Yes

Product Code : ELR

Prescription Use : Yes

Device Count : 1

AccessPost - 00766054000389 Catalog Number : 530-01

Device Description : AccessPost Refill 10 Pack Size 1

Device Class : 1

Duns Number: 101147171

Premarket Exempt : Yes

Product Code : ELR

Prescription Use : Yes

Device Count : 1

AccessPost - 00766054000396 Catalog Number : 530-02

Device Description : AccessPost Refill 10 Pack Size 2

Device Class : 1

Duns Number: 101147171

Premarket Exempt : Yes

Product Code : ELR

Prescription Use : Yes

Device Count : 1

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